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The Winner of the PMA Race Is . . .

Article-The Winner of the PMA Race Is . . .

The Winner of the PMA Race Is . . .
In an analysis of FDA approvals for medical device PMAs, one state is the obvious winner, with the shortest time to approval. Which state is home to the quickest PMA approvals?

In an analysis of FDA approvals for medical device PMAs, one state is the obvious winner, with the shortest time to approval. Which state is home to the quickest PMA approvals?

Marie Thibault

Minnesota wins again as the state with the fastest regulatory approvals. After being crowned a few weeks ago as the state with the shortest average time for 510(k) clearances—115 days—a new analysis shows that Minnesota also has the fastest average time for first PMA approvals, at 376 days.

Both analyses were conducted by Minnesota trade association LifeScience Alley using data from Evaluate Medtech, part of the Evaluate market intellegence company. The latest report finds that the North Star State beat the 575-day national average for first PMA approvals by 199 days.  

Cheryl Matter, PhD, vice president of Intelligence and Research at LifeScience Alley, says that there are a number of factors that may give Minnesota an advantage on regulatory issues. For one, she points out, Minnesota is known for innovation, especially in the area of cardiology, and that could be one reason the state saw its cardiology PMA approvals come in 73 days faster than the national average for cardiology. Matter says that while speaking about the issue with Minnesotans in the medtech industry, many of them referenced the combination of expertise, talent, and long experience in the state. "I like to think we've been doing this for a long time," Matter says. 

Other contributing factors include the concentration of and close partnerships between original equipment manufacturers and suppliers, as well as the wealth of talent being trained at major medical device companies like Medtronic, Boston Scientific, and St. Jude Medical. "A lot of the talent grew up in those companies," Matter says. This means many of those employees have eventually moved on to form new medtech companies or consulting businesses that continue to add to the state's regulatory know-how.

Other findings from the LifeScience Alley analysis include the fact that between 2010–2014, the top three states for the number of first PMA approvals were California with 51 approvals, Minnesota with 18 approvals, and Indiana with 13 approvals. These three states contributed 59% of the total first PMA approvals between 2010-2014, Fewer than half of the country's states—just 23 states—could claim first PMA approvals during that time frame. In contrast, the top three states for 510(k) clearances—Minnesota, California, and Massachusetts—accounted for only 36% of all filings and 510(k) applications came from 47 states during those years, according to LifeScience Alley's Alley Insights

Minnesota is also a major player when it comes to PMA supplemental approvals. Companies from Minnesota received 41% of all PMA supplemental approvals between 2010–2014 and the state beat the national average approval time by 18 days.

Besides bragging rights, a faster PMA approval can mean big dollars for medtech companies. Matter says that the financial impact of waiting for PMA approval can be significant, particularly for a small company that might be spending $1–3 million a month awaiting approval and ramping for production. Additionally, the opportunity cost of getting earlier market access may be harder to count, but is just as meaningful, she says.

Overall, PMA approval times are getting shorter. In 2014, FDA granted first PMA approvals in about half the time it took in 2013.

Everything seems to be coming up roses for Minnesota these days. CNBC also reported today that the state was named the top state for business in 2015, according to a study conducted by the media outlet. Perhaps the more than 36,000 medical device workers in Minnesota agree. 

Enhance your medtech knowledge by attending MEDevice San Diego, September 1–2, 2015, in San Diego.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie


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